Retractable blade for lead removal device

ABSTRACT

Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient&#39;s vasculature system. Specifically, the tissue separating device includes a handle, an elongate sheath and a circular cutting blade that may extend from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device&#39;s elongate shaft. The tissue separating device includes a cam mechanism at the distal portion of the sheath that allows the user of the device to more accurately control the extension and rotation of the cutting blade upon being actuated by the handle.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to devices, methods and systemsfor separating tissue in a patient, and more specifically, to devicesfor separating tissue attached to implanted objects, such as leads, in apatient and removing such objects.

BACKGROUND

Surgically implanted cardiac pacing systems, such as pacemakers anddefibrillators, play an important role in the treatment of heartdisease. In the 50 years since the first pacemaker was implanted,technology has improved dramatically, and these systems have saved orimproved the quality of countless lives. Pacemakers treat slow heartrhythms by increasing the heart rate or by coordinating the heart'scontraction for some heart failure patients. Implantablecardioverter-defibrillators stop dangerous rapid heart rhythms bydelivering an electric shock.

Cardiac pacing systems typically include a timing device and a lead,which are placed inside the body of a patient. One part of the system isthe pulse generator containing electric circuits and a battery, usuallyplaced under the skin on the chest wall beneath the collarbone. Toreplace the battery, the pulse generator must be changed by a simplesurgical procedure every 5 to 10 years. Another part of the systemincludes the wires, or leads, which run between the pulse generator andthe heart. In a pacemaker, these leads allow the device to increase theheart rate by delivering small timed bursts of electric energy to makethe heart beat faster. In a defibrillator, the lead has special coils toallow the device to deliver a high-energy shock and convert potentiallydangerous rapid rhythms (ventricular tachycardia or fibrillation) backto a normal rhythm. Additionally, the leads may transmit informationabout the heart's electrical activity to the pacemaker.

For both of these functions, leads must be in contact with heart tissue.Most leads pass through a vein under the collarbone that connects to theright side of the heart (right atrium and right ventricle). In somecases, a lead is inserted through a vein and guided into a heart chamberwhere it is attached with the heart. In other instances, a lead isattached to the outside of the heart. To remain attached to the heartmuscle, most leads have a fixation mechanism, such as a small screwand/or hooks at the end.

Within a relatively short time after a lead is implanted into the body,the body's natural healing process forms scar tissue along the lead andpossibly at its tip, thereby fastening it even more securely in thepatient's body. Leads usually last longer than device batteries, soleads are simply reconnected to each new pulse generator (battery) atthe time of replacement. Although leads are designed to be implantedpermanently in the body, occasionally these leads must be removed, orextracted. Leads may be removed from patients for numerous reasons,including but not limited to, infections, lead age, and leadmalfunction.

Removal or extraction of the lead may be difficult. As mentioned above,the body's natural healing process forms scar tissue over and along thelead, and possibly at its tip, thereby encasing at least a portion ofthe lead and fastening it even more securely in the patient's body. Inaddition, the lead and/or tissue may become attached to the vasculaturewall. Both results may, therefore, increase the difficulty of removingthe leads from the patient's vasculature.

A variety of tools have been developed to make lead extraction safer andmore successful. Current lead extraction techniques include mechanicaltraction, mechanical devices, and laser devices. Mechanical traction maybe accomplished by inserting a locking stylet into the hollow portion ofthe lead and then pulling the lead to remove it. An example of such alead locking device is described and illustrated in U.S. Pat. No.6,167,315 to Coe et al., which is hereby incorporated herein byreference in its entirety for all that it teaches and for all purposes.

A mechanical device to extract leads includes a flexible tube called asheath that passes over the lead and/or the surrounding tissue. Thesheath typically may include a cutting blade, such that uponadvancement, the cutting blade and sheath cooperate to separate the scartissue from other scar tissue including the scar tissue surrounding thelead. In some cases, the cutting blade and sheath may also separate thetissue itself from the lead. Once the lead is separated from thesurrounding tissue and/or the surrounding tissue is separated from theremaining scar tissue, the lead may be inserted into a hollow lumen ofthe sheath for removal and/or be removed from the patient's vasculatureusing some other mechanical devices, such as the mechanical tractiondevice previously described in United States Patent Publication No.2008/0154293 to Taylor, which is hereby incorporated herein by referencein its entirety for all that it teaches and for all purposes.

Some lead extraction devices include mechanical sheaths that havetrigger mechanisms for extending the blade from the distal end of thesheath. An example of such devices and method used to extract leads isdescribed and illustrated in U.S. Pat. No. 5,651,781 to Grace, which ishereby incorporated herein by reference in its entirety for all that itteaches and for all purposes.

Controlling the extension of the blade within a patient's vasculaturemay be critical, particularly when the sheath and blade negotiatetortuous paths that exist in certain vascular or physiologicalenvironments. Furthermore, in certain cases, using such mechanicaldevices for lead removal may require more precise control, such as whenthe leads are located in, and/or attached to a structurally-weak portionof the vasculature. For instance, typical leads in a human may passthrough the innominate vein, past the superior vena cava (“SVC”), andinto the right atrium of the heart. Tissue growth occurring along theSVC and other locations along the innominate vein may increase the riskand difficulty in extracting the leads from such locations, particularlywhen the vein(s)' walls are thin. Tissue growth may also occur at otherchallenging locations within a patient's vasculature which requires thedelicate and precise control of the devices used to extract leads fromsuch locations.

SUMMARY

Accordingly, there is a need for a device, method and/or system such asa surgical device that has the capability to precisely control theextension and rotation of a blade from a sheath. For example, it may bedesirable for the blade to initially extend a relatively short distanceand/or rotate relatively slowly initially upon actuation, and it may bedesirable for the blade to extend further and/or rotate relatively morequickly later during actuation. The present disclosure discusses a cammechanism incorporated within a surgical device, thereby providing theclinician the appropriate and variable precision and coarse controlduring using this device. Additionally, the present disclosuresdiscusses a distal tip having a configuration that assists in holdingthe device in place as the blade extends and rotates therefrom, therebypotentially further increasing the clinician's precision during use ofthe device.

A method in accordance with this disclosure may include tissuesurrounding at least a portion an object implanted within a body vessel,the method comprising the steps of (a) placing an the implanted objectinto a lumen of an elongated sheath, the elongated sheath comprising adistal tip and a tubular member housed within at least a portion of thedistal tip, wherein the tubular member has a cutting surface facingdistally, (b) rotating and extending the cutting surface of the tubularmember beyond the distal tip and into the tissue at a first rate for afirst distance, (c) and rotating and extending the cutting surface ofthe tubular member beyond the distal tip and into the tissue at a secondrate for a second distance.

A device in accordance with this disclosure for removing an implantedobject from a body vessel, may comprising a (i) handle, (ii) anelongated sheath having a proximal end, a distal end, and a lumenextending from the distal end toward the proximal end, wherein the lumenis configured to receive an implanted object, the elongated sheathfurther comprising a proximal portion and a distal portion, (iii) ahollow circular outer member attached to the distal portion of theelongated sheath, (iv) a pin attached to the hollow circular outermember and extending inwardly thereof, and (v) a hollow circular innermember located within the outer member, the hollow circular inner membercomprising a proximal end, a distal end and an exterior surfacetherebetween, the distal end comprising a cutting surface, the exteriorsurface of the inner member comprising a cam slot for receipt of andcooperation with the pin such that upon actuation of the handle, theinner member rotates and the distal end of the inner member extendsbeyond the distal end of the elongated sheath.

The device may include a means for rotating the elongated sheath,whereupon rotation of the elongated sheath, the inner member movesaccording to the predetermined profile. The means for rotating theelongated sheath may include a handle, and one or more gears connectingthe handle to the elongated inner sheath. Alternatively, the means forrotating the elongated sheath may include a switch, and a motorcomprising a shaft connected to the elongated inner sheath.

The device may also include an indicator indicative of the amount ofextension that the inner member extends beyond the distal end of theelongated sheath.

The phrases “at least one”, “one or more”, and “and/or” are open-endedexpressions that are both conjunctive and disjunctive in operation. Forexample, each of the expressions “at least one of A, B and C”, “at leastone of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B,or C” and “A, B, and/or C” means A alone, B alone, C alone, A and Btogether, A and C together, B and C together, or A, B and C together.When each one of A, B, and C in the above expressions refers to anelement, such as X, Y, and Z, or class of elements, such as X₁-X_(n),Y₁-Y_(m), and Z₁-Z_(o), the phrase is intended to refer to a singleelement selected from X, Y, and Z, a combination of elements selectedfrom the same class (e.g., X₁ and X₂) as well as a combination ofelements selected from two or more classes (e.g., Y₁ and Z_(o)).

The term “a” or “an” entity refers to one or more of that entity. Assuch, the terms “a” (or “an”), “one or more” and “at least one” may beused interchangeably herein. It is also to be noted that the terms“comprising”, “including”, and “having” may be used interchangeably.

A “lead” is a conductive structure, typically an electrically insulatedcoiled wire. The electrically conductive material may be any conductivematerial, with metals and intermetallic alloys common. The outer sheathof insulated material is biocompatible and bio stable (e.g.,non-dissolving in the body) and generally includes organic materialssuch as polyurethane and polyimide. Lead types include, by way ofnon-limiting example, epicardial and endocardial leads. Leads arecommonly implanted into a body percutaneously or surgically.

The term “means” as used herein shall be given its broadest possibleinterpretation in accordance with 35 U.S.C., Section 112, Paragraph 6.Accordingly, a claim incorporating the term “means” shall cover allstructures, materials, or acts set forth herein, and all of theequivalents thereof. Further, the structures, materials or acts and theequivalents thereof shall include all those described in the summary ofthe invention, brief description of the drawings, detailed description,abstract, and claims themselves.

A “serration” or “serrated edge” or “serrated blade” or othervariations, as used herein, shall mean the configuration of a cuttingsurface having a notched edge or saw-like teeth. The notched edgescreate a plurality of smaller points that contact (and therefore lesscontact area with) the material being cut in comparison to an un-notchedblade. Additionally, the pressure applied by each serrated point ofcontact is relatively greater and the points of contact are at a sharperangle to the material being cut. One example of a serrated blade mayinclude one notch adjacent to and abutting another notch such that thereis very little, if any, blade between such notches, thereby creatingpoints of contact. There are multiple variations and/or features ofserrations. For example, one type of serrated feature is referred to asa “crown.” As used herein, a serrated blade, or other variation, in theshape of a “crown,” shall mean a blade comprising a plurality of notchesand adjacent un-notched areas such that the combination of notched andun-notched areas resembles a crown for a royal member (e.g., king,queen, etc.), particularly when the blade is circular. A further type of“crown” includes a “hook crown.” As used herein, a serrated blade, orother variation, in the shape of a “hook crown,” shall mean a bladecomprising a plurality of notches and adjacent un-notched areas, whereinthe length of un-notched areas of the blade are longer than the notchedareas of the blade.

A “surgical implant” is a medical device manufactured to replace amissing biological structure, support, stimulate, or treat a damagedbiological structure, or enhance, stimulate, or treat an existingbiological structure. Medical implants are man-made devices, in contrastto a transplant, which is a transplanted biomedical tissue. In somecases implants contain electronics, including, without limitation,artificial pacemaker, defibrillator, electrodes, and cochlear implants.Some implants are bioactive, including, without limitation, subcutaneousdrug delivery devices in the form of implantable pills or drug-elutingstents.

It should be understood that every maximum numerical limitation giventhroughout this disclosure is deemed to include each and every lowernumerical limitation as an alternative, as if such lower numericallimitations were expressly written herein. Every minimum numericallimitation given throughout this disclosure is deemed to include eachand every higher numerical limitation as an alternative, as if suchhigher numerical limitations were expressly written herein. Everynumerical range given throughout this disclosure is deemed to includeeach and every narrower numerical range that falls within such broadernumerical range, as if such narrower numerical ranges were all expresslywritten herein.

The preceding is a simplified summary of the disclosure to provide anunderstanding of some aspects of the disclosure. This summary is neitheran extensive nor exhaustive overview of the disclosure and its variousaspects, embodiments, and configurations. It is intended neither toidentify key or critical elements of the disclosure nor to delineate thescope of the disclosure but to present selected concepts of thedisclosure in a simplified form as an introduction to the more detaileddescription presented below. As will be appreciated, other aspects,embodiments, and configurations of the disclosure are possibleutilizing, alone or in combination, one or more of the features setforth above or described in detail below

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are incorporated into and form a part of thespecification to illustrate several examples of the present disclosure.These drawings, together with the description, explain the principles ofthe disclosure. The drawings simply illustrate preferred and alternativeexamples of how the disclosure may be made and used and are not to beconstrued as limiting the disclosure to only the illustrated anddescribed examples. Further features and advantages will become apparentfrom the following, more detailed, description of the various aspects,embodiments, and configurations of the disclosure, as illustrated by thedrawings referenced below.

FIG. 1 is a perspective view of a human having a pacemaker lead locatedin the venous system and terminating electrode anchored to theventricular heart chamber, with an embodiment of a surgical device beingshown inserted into the body and partly advanced over the lead;

FIG. 2 is an elevation view of an embodiment of a surgical device;

FIG. 2A is an elevation view of an alternative embodiment of a surgicaldevice;

FIG. 3 is a cross-sectional view of a cutting sheath assembly within ablood vessel with an extendable and rotatable blade for removing a leadaccording to an embodiment of the disclosure;

FIG. 4A is an end view of the distal portion of the cutting sheathassembly according to an embodiment of the disclosure;

FIG. 4B is a cross-sectional view of the distal portion of the cuttingsheath assembly according to an embodiment of the disclosure, wherein aninner member is in a retracted position within the cutting sheathassembly;

FIG. 4C is a cross-sectional view of the distal portion of the cuttingsheath assembly according to an embodiment of the disclosure, wherein aninner member is in an extended position within the cutting sheathassembly;

FIG. 5A is a cross-sectional view of the distal portion of the cuttingsheath assembly according to an embodiment of the disclosure, wherein aninner sheath is in a retracted position;

FIG. 5B is cross-sectional view of the distal portion of the cuttingsheath assembly according to an alternate embodiment of the disclosure,wherein an inner sheath is in an extended position;

FIG. 6A is perspective view of an outer band member according to anembodiment of the disclosure;

FIG. 6B is an end view of the outer band member illustrated in FIG. 6A;

FIG. 6C is cross-sectional view of the outer band member illustrated inFIG. 6A taken along line 6C-6C of FIG. 6B;

FIG. 7A is perspective view of an inner band member according to anembodiment of the disclosure;

FIG. 7B is side view of the inner band member illustrated in FIG. 7A;

FIG. 7C is end view of the inner band member illustrated in FIG. 7A;

FIG. 7D is cross-sectional view of the inner band member illustrated inFIG. 7A taken along line 7D-7D in FIG. 7C;

FIG. 8A is perspective view of an inner band member according to anembodiment of the disclosure;

FIG. 8B is side view of the inner band member illustrated in FIG. 8A;

FIG. 8C is end view of the inner band member illustrated in FIG. 8A;

FIG. 8D is cross-sectional view of the inner band member illustrated inFIG. 8A taken along line 8D-8D in FIG. 8C;

FIG. 9A is perspective view of an inner band member according to anembodiment of the disclosure;

FIG. 9B is side view of the inner band member illustrated in FIG. 9A;

FIG. 9C is end view of the inner band member illustrated in FIG. 9A;

FIG. 9D is cross-sectional view of the inner band member illustrated inFIG. 9A taken along line 9D-9D in FIG. 9C;

FIG. 10A is perspective view of an inner band member according to anembodiment of the disclosure;

FIG. 10B is side view of the inner band member illustrated in FIG. 10A;

FIG. 10C is end view of the inner band member illustrated in FIG. 10A;

FIG. 10D is cross-sectional view of the inner band member illustrated inFIG. 10A taken along line 10D-10D in FIG. 10C;

FIG. 11A is perspective view of an inner band member according to anembodiment of the disclosure;

FIG. 11B is side view of the inner band member illustrated in FIG. 11A;

FIG. 11C is end view of the inner band member illustrated in FIG. 11A;

FIG. 11D is cross-sectional view of the inner band member illustrated inFIG. 11A taken along line 11D-11D in FIG. 11C;

FIG. 12A is perspective view of an inner band member according to anembodiment of the disclosure;

FIG. 12B is side view of the inner band member illustrated in FIG. 12A;

FIG. 12C is end view of the inner band member illustrated in FIG. 12A;

FIG. 12D is cross-sectional view of the inner band member illustrated inFIG. 12A taken along line 12D-12D in FIG. 12C;

FIG. 13A is perspective view of an inner band member according to anembodiment of the disclosure;

FIG. 13B is side view of the inner band member illustrated in FIG. 13A;

FIG. 13C is end view of the inner band member illustrated in FIG. 13A;

FIG. 13D is cross-sectional view of the inner band member illustrated inFIG. 13A taken along line 13D-13D in FIG. 13C;

FIG. 14A is a side view of the outer member with the inner member ofFIGS. 7A-7D positioned in a retracted position within the outer sheath;

FIG. 14B is a side view of the outer member with the inner member ofFIGS. 7A-7D positioned in an extended position within the outer sheath;

FIG. 15 is an illustration of the geometry of the cam slot of the innermember illustrated in FIGS. 7A-7D portrayed on a single plane;

FIG. 16A is a side view of the outer member with the inner member ofFIGS. 8A-8D positioned in a retracted position within the outer sheath;

FIG. 16B is a side view of the outer member with the inner member ofFIGS. 8A-8D positioned in a partially extended position within the outersheath;

FIG. 16C is a side view of the outer member with the inner sheath ofFIGS. 8A-8D positioned in a fully extended position within the outermember;

FIG. 17 is an illustration of the geometry of the cam slot of the innermember illustrated in FIGS. 8A-8D portrayed on a single plane;

FIG. 18 is a perspective view of an inner member having a cam slot withan extended stow region;

FIG. 19A is a side view of the outer member with the inner member ofFIG. 18 positioned in a retracted position within the outer sheath;

FIG. 19B is a side view of the outer member with the inner member ofFIG. 18 positioned in a partially extended position within the outersheath;

FIG. 19C is a side view of the outer member with the inner member ofFIG. 18 positioned in a fully extended position within the outer sheath;

FIG. 20 is an illustration of the geometry of the cam slot of the innermember illustrated in FIG. 18 portrayed on a single plane;

FIG. 21 is a perspective view of an inner member having a duplex camslot;

FIG. 22A is a side view of the outer member with the inner member ofFIG. 21 positioned in a retracted position within the outer sheath;

FIG. 22B is a side view of the outer member with the inner member ofFIG. 21 positioned in a partially extended position within the outersheath.

FIG. 22C is a side view of the outer member with the inner member ofFIG. 21 positioned in a fully extended position within the outer sheath;

FIG. 23 is an illustration of the geometry of the cam slot of the innermember illustrated in FIG. 21 portrayed on a single plane;

FIG. 24 is a perspective view of an embodiment of a handle portion,including an indicator, of the surgical device;

FIG. 25 is a perspective view of an alternate embodiment of a handleportion, including an alternate indicator, of the surgical device;

FIG. 26 is a side view of an alternate embodiment of a handle portion,including an alternate indicator, of the surgical device;

FIG. 27 is a perspective view of an alternate embodiment of a handleportion, including an alternate indicator, of the surgical device;

FIG. 28 is a cross-sectional view of the distal portion of the cuttingsheath assembly according to an alternate embodiment of the disclosure,wherein a cutting blade in a refracted position;

FIG. 29A is perspective view of a distal tip of the outer sheathaccording to an embodiment of the disclosure;

FIG. 29B is side view of the distal tip illustrated in FIG. 29A;

FIG. 29C is proximal end view of the distal tip illustrated in FIG. 29A;

FIG. 29D is distal end view of the distal tip illustrated in FIG. 29A;

FIG. 30A is perspective view of a distal tip of the outer sheathaccording to an embodiment of the disclosure;

FIG. 30B is side view of the distal tip illustrated in FIG. 30A;

FIG. 30C is proximal end view of the distal tip illustrated in FIG. 30A;

FIG. 30D is distal end view of the distal tip illustrated in FIG. 30A;

FIG. 31A is perspective view of a distal tip of the outer sheathaccording to an embodiment of the disclosure;

FIG. 31B is side view of the distal tip illustrated in FIG. 31A;

FIG. 31C is proximal end view of the distal tip illustrated in FIG. 31A;

FIG. 31D is distal end view of the distal tip illustrated in FIG. 31A;

FIG. 32A is a perspective view of an inner member in a retractedposition within a distal tip of an outer according to an embodiment ofthe disclosure; and

FIG. 32B is a perspective view of the inner member of FIG. 32A in anextended or partially extended position with respect to the distal tip.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

DETAILED DESCRIPTION

Before any embodiments of the disclosure are explained in detail, it isto be understood that the disclosure is not limited in its applicationto the details of construction and the arrangement of components setforth in the following description or illustrated in the followingdrawings. The disclosure is capable of other embodiments and of beingpracticed or of being carried out in various ways. Also, it is to beunderstood that the phraseology and terminology used herein is for thepurpose of description and should not be regarded as limiting. The useof “including,” “comprising,” or “having” and variations thereof hereinis meant to encompass the items listed thereafter and equivalentsthereof as well as additional items.

Embodiments according to this disclosure provide a surgical device thatincludes a sheath, which can be deployed safely within a vascular systemof a patient and separate implanted objects, such as leads, from apatient's vasculature system. FIG. 1 depicts a surgical device 108having a sheath 112 inserted within an exemplary patient 104. The sheath112 surrounds an implanted lead (not shown) running along the leftinnominate vein past the SVC and connected into, or about, the rightventricle of the heart. Upon surrounding the lead with the sheath, theuser of the surgical device may actuate the handle, thereby extending acutting blade (not shown) beyond the distal end of the sheath 112 to cutthe tissue surrounding the lead within the patient's SVC. When theclinician releases the handle, the cutting blade returns within thesheath 112, thereby allowing the clinician to force and advance thedistal portion of the sheath against additional uncut tissue. Theclinician repeats the actuation step, thereby causing the cutting bladeto re-appear and extend beyond the distal end of the sheath 112 to cutthe adjacent tissue. Each time actuation occurs, the proximal portion ofthe implanted lead and/or surrounding tissue enters into a hollowpassageway within the sheath 112. This process is again repeated untilthe implanted lead and/or surrounding tissue is completely orsubstantially separated from the tissue attached to the SVC. At thattime, the implanted lead may safely be removed from the patient's SVC.

With reference to FIG. 2, an exemplary surgical device 200 is depicted.The surgical device 200 includes a handle 204 and an outer sheath 208.The surgical device also includes an inner sheath (not shown) locatedwithin the outer sheath 208. It may be preferable for the outer sheath208 to remain stationary while the inner sheath is capable of moving(e.g., rotating and extending) with respect to the outer sheath 208. Theinner sheath and outer sheath 208 can both be flexible, rigid or acombination thereof.

The handle 204 includes a trigger 212 which pivots about a pin (notshown) that attaches the trigger 212 to the handle 204. Attached to theportion of the trigger 212 within the handle 204 is a first gear (notshown). Also included within the handle 204 is second gear and a thirdgear (both of which are not shown). The first gear meshes with thesecond gear, which in turn meshes with the third gear. The third gearhas an opening through its center, wherein the opening is sized andconfigured to allow the inner sheath to be inserted and affixed thereto.When a user (i.e., clinician) actuates the handle 204, it pivots aboutthe pin, thereby causing the handle 204 and first gear to move in acounter clockwise direction. The first gear engages the second gear andcauses the second gear to rotate. The second gear, in turn, engages thethird gear initiating it and the inner sheath to rotate about thesheath's longitudinal axis A-A.

The handle may also include a spring (not shown) that is attached to thegears, sheath and/or some other member therein such that, upon theclinician's release of the handle, the spring facilitates rotation ofthe inner sheath in a direction opposite to that in which it rotatedupon actuation of the handle 204. It may be preferable for the innersheath to rotate in a clockwise direction about its longitudinal axisfrom the perspective of the proximal end of the surgical device 200. Ifso, the spring will facilitate the inner sheath rotation in acounter-clockwise direction upon the clinician's release of the trigger212.

The trigger 212 and gears are one example of an actuation means forcausing the inner sheath to rotate about its longitudinal axis. However,a variety of different triggers and gearing may cooperate to rotate theinner sheath. For example, the trigger 212 depicted in FIG. 1 includestwo openings 216, 220. A trigger, however, may have less than or morethan two openings. Additionally, a trigger may also be comprised of astraight or non-linear member without any openings. Furthermore, atrigger may be in the shape of a button capable of being depressed. Aslong as the trigger, either alone or in conjunction with the handle, isergonomically correct and comfortable for the clinician, the trigger mayhave a variety of sizes and shapes.

The actuation means discussed above includes three gears. A lower orhigher number of gears, however, may be used in lieu of three gears.Many different types of gears are available. Non-limiting examples ofgears include, but are not limited to, spur gears, helical gears, doublehelical gears, bevel gears, spiral bevel gears, hypoid gears, crowngears, worm gears, non-circular gears, rack and pinion gears, epicyclicgears, sun and planet gears, harmonic drive gears, cage gears, andmagnetic gears. Any one and/or combination of these types or other typesof gears could be used.

The trigger 212 and gear(s) configuration discussed above is an exampleof a mechanical actuation means to rotate the inner sheath. In analternate embodiment, the actuation means may comprise electromechanicalcomponents. For example, the actuation means may comprise an electricmotor (not shown) having a driven shaft that is directly or indirectlycoupled to the inner sheath. The motor's shaft may be indirectly coupledto the inner sheath by one or more gears discussed hereinbefore. Themotor may be controlled by a switch, thereby causing the inner sheath torotate in a clockwise and/or a counterclockwise direction upon actuatinga switch that may also act as the trigger. The electric motor may beeither a direct current (DC) motor or an alternating current (AC) motor.Accordingly, the motor may be powered by a DC source, such as a battery,or an AC source, such as a conventional power cord. Additionally, thoseskilled in the art will appreciate that there are numerous other ways inwhich a surgical device comprising a rotatable sheath may be actuatedand driven.

It may be preferable for a portion of the outer sheath to be rigid and aportion of the outer sheath to be flexible. With reference to FIG. 2A,an exemplary surgical device 200′ comprising an outer sheath having arigid outer portion 222 and a flexible outer portion 224 is depicted.Both the rigid outer portion 222 and a flexible outer portion 224 areconstructed of materials suitable for insertion into the human body. Forexample, the rigid outer portion 222 may be constructed of stainlesssteel, and the flexible outer portion 224 may be constructed of aflexible polymer such as polytetrafluoroethylene or thermoplasticelastomers.

The rigid outer portion 222 and flexible outer portion 224 form aunitary outer sheath. The rigid outer portion 222 has a proximal end 236and a distal end 238. Similarly, the flexible outer portion 224 has aproximal end 228 and a distal end 232. The distal end 238 of the rigidouter portion 222 is connected to the proximal end 228 of the flexibleouter portion 224, thereby forming a unitary outer sheath. Themechanism(s) to connect the distal end 238 of the rigid outer portion222 and the proximal end 228 of the flexible outer portion 224 are notdescribed herein and are conventional, and need not be further explainedor illustrated to enable one skilled in the art to utilize the mechanismfor the purposes described. For example, the configuration and/or shapeof the proximal end 228 may be such that it may interlock with thedistal end 238 for example via a barbed joint. Although the interlockmechanism described herein may be preferred, it is not intended torepresent the only way that such a connection can be accomplished. Allsuch techniques within the knowledge of one skilled in the art areconsidered within the scope of this disclosure.

Similar to the flexible outer sheath 224, the inner sheath is generallyflexible in order to accept, accommodate and navigate the patient'svasculature system. In addition to being flexible, the inner sheath mayalso have a high degree of stiffness in order to receive the torquetransferred from the actuation means and transfer sufficient torque tothe cutting blades discussed in more detail below. The inner sheath maybe formed of a polymer extrusion, braided reinforced polymer extrusion,coils, bi-coils, tri-coils, laser cut metal tubing and any combinationof the above. The inner sheath may be a unitary structure comprised ofmultiple portions. If the inner sheath has multiple portions, some ofthose portions may be rigid. For example, similar to the rigid outersheath 222, some or all of the portions of the inner sheath locatedwithin the rigid outer sheath 222 may also be rigid. If the inner sheathhas multiple portions, those multiple portions may be attached in amanner similar to the manner in which the rigid outer sheath 222 andflexible outer sheath 224 are connected.

With reference to FIGS. 4A, 4B and 4C, an exemplary distal portion ofthe flexible inner and outer sheaths of a surgical device is depicted.The assembly 400 includes a flexible inner sheath 426 located withinflexible outer sheath 404. Attached to the distal portion of theflexible outer sheath 404 is an outer cam member 408, which is discussedin more detail below. The distal end of the flexible outer sheath 404 isgenerally smooth and evenly rounded at its most distal point, therebyallowing it to act as a dilator when pressed and forced against tissue.And the distal end of the outer cam member 408 is also longitudinallyaligned with the distal end of the flexible outer sheath 404. The distalend 430 of the flexible inner sheath 426 is connected to the proximalend 418 of inner cam member 412, which is discussed in more detailbelow. The distal end 422 of inner cam member 412 includes a cuttingsurface capable of cutting tissue.

The inner sheath 426 is coupled to the outer sheath 404 through theinner cam member 412 and the outer cam member 408 via pin 410. One endof the pin 410 is fixed within the outer cam member 412, and the otherend of the pin 410 is located within the cam slot 414 of the inner cammember 412. As the inner sheath 426 extends, via the actuation meansdiscussed above, the inner cam member 412 extends distally in thedirection of the arrow (→) and rotates according to the profile of thecam slot 414. As the inner cam member 412 extends distally and rotates,the outer sheath 404, outer cam member 408 and pin 412 remainstationary. Thus, as the inner cam member 412 extends distally (andpotentially proximally according to the cam slot profile) and rotatesthe cutting surface at the distal end 422 of the inner cam member 412 isable to perform a slicing action against the tissue and cut it.

FIG. 4B depicts the inner cam member 412 within a retracted (andun-actuated) position because the inner cam member 412 is in its mostproximal position. Stated differently, the distal end 422 of the innercam member 412 of FIG. 4B is located within the interior of the outercam member 408 and does not extend beyond the distal end of the outercam member 408. With reference to FIG. 4C, the inner cam member 412 isdepicted in an extended (and actuated) position because the inner cammember 412 is in its most distal position extending beyond the distalend of the flexible outer sheath 404 and the outer cam member 408.

FIG. 3 depicts the distal portion of the flexible outer sheath andflexible inner sheath of FIG. 4C surrounding a lead 530 within apatient's vein 534 with the inner cam member 412 in its extendedposition. The circumferential nature of the cutting blade at the distalend of the inner cam member causes the surgical device to act as acoring device, thereby cutting tissue 538 either partially (i.e., lessthan 360 degrees) or completely (i.e., 360 degrees) around the lead orimplanted object being extracted. The amount of tissue that the bladecuts depends upon the size, shape and configuration of the lead, as wellas the diameter and thickness of the circular cutting blade. Forexample, if the diameter of the circular blade is substantially greaterthan the diameter of the lead, then the blade will cut and core moretissue in comparison to a cutting blade having a smaller diameter. Oncethe desired cut has been made, the operator releases trigger and theinner cam member (including the blade) returns to its retractedposition. Once the blade is in the retracted position, the distal tip408 of the cam member 404 (and/or outer sheath) safely acts as adilating device, thereby stretching tissue as the sheaths move over thelead or implanted object to be extracted.

Although the inner sheath and outer sheath are coupled to one anothervia the inner cam member, outer cam member, and pin, the sheaths may becoupled to one another in other ways. Stated differently, those of skillin the art will understand how to make and use the disclosed aspects,embodiments, and/or configurations after understanding the presentdisclosure to couple the sheaths in a manner to allow a cutting surfaceto extend and rotate beyond the distal end of the outer sheath. All suchconfigurations within the knowledge of one skilled in the art areconsidered within the scope of this disclosure. For example, referringto FIGS. 5A and 5B, the assembly 500 may include an outer sheath 504 andan inner sheath 526 coupled to one another via pin 510 without the useof an outer cam member or inner member as in FIGS. 4B and 4C. The outersheath 504 may have a pin 510 connected to it, and the inner sheath 526may include cam slot 514 such that as the inner sheath 526 extends uponactuation of the actuation means discussed earlier herein, the innersheath 526 along with its cutting surface, also rotates according to thecam slot 514 profile. While the inner sheath 526 extends and rotates,the outer sheath 504 and pin 510 remain stationary. FIG. 5A depicts theinner sheath 526 (and cutting surface 522) of assembly 500 in aninitially retracted and stowed position. FIG. 5B depicts the innersheath 526 (and cutting surface 522) of assembly 500′ in an extendedposition. As the actuation means is actuated and un-actuated, theassembly moves from a refracted position to an extended position andvice versa.

With reference to FIGS. 6A, 6B and 6C, an exemplary outer cam member 600is depicted. The outer cam member 600 is a sleeve in the shape of ahollow cylinder. Although the exterior of the outer cam member 600 isuniform, it need not be. The interior of the outer cam member 600 is notuniform. For example, the interior of the outer cam member 600 includesan abutment 616 to prevent the inner cam member (not shown) fromtraveling further from the proximal end 612 to the distal end 608 withinthe outer cam member 600. The outer cam member 600 also includes a hole604 for receipt and possible attachment of a pin (not shown) whichprotrudes radially inward. As discussed in more detail below, the pinengages the cam slot of the inner cam member. The size, shape andconfiguration of the outer cam member 600 may differ depending upon howit is attached to the flexible outer sheath. As discussed above, theouter sheath may be stationary. If so, the outer cam member 600 and thepin remain stationary as the inner cam member moves relatively thereto.

With reference to FIGS. 7A, 7B, 7C and 7D, an exemplary inner cam member700 is depicted. The inner cam member 700 has a generally hollowcylindrical shape. The inner cam member 700 comprises a proximal portion724, an intermediate portion 728, and a distal portion 732. The outsidediameter of the proximal portion 724 is sized to allow the distal end704 of the inner cam member 700 to be inserted to and engage (orotherwise attached to) the interior diameter of the inner flexiblesheath (not shown). The distal end 708 of the inner cam member 700comprises a cutting surface 712 having a flat, sharp blade profile. Theintermediate portion 728 comprises a cam slot 716 cut within itsexterior surface. As the inner flexible sheath rotates and moves withinthe outer sheath—from its proximal end to distal end—the outer sheathand pin may remain stationary. If so, the inner sheath, which isconnected to the inner cam member, forces the inner cam member to rotateand move toward the distal end of the outer sheath. The cam slot 716engages the pin, and the shape and profile of the cam slot 716 controlsthe rate and distance with which the inner cam member 700 travels. Thatis, the configuration of the cam slot controls how the inner cam membertravels both laterally and rotationally.

The cam slot 716 in FIGS. 7A, 7B, 7C and 7D can have a linear profile(not shown). An alternative example of a two dimensional representationof the profile of the cam slot is depicted in FIG. 15. When the pin isposition A on the left hand side of FIG. 15, the inner cam member (andblade) is in the retracted position, as depicted in FIG. 14A. As theinner cam member rotates about 180 degrees and extends (from left toright in FIG. 15), the cam slot 1504 travels along the pin from positionA to position B at a relatively constant rate because the slope of thecam slot between these two points is relatively linear. That is, thereis a substantially linear portion within the cam slot 1504 betweenposition A and position B even though the overall shape of the cam slot1504 is generally sinusoidal. The sinusoidal shape, particularly at thetransition points, namely position A and position B, allows for a smoothtransition from extension to retraction through such positions whilemaintaining a relatively constant rate of rotation. Upon reachingposition B, the inner cam member is in its fully extended position, asdepicted in FIG. 14B. As the inner cam member continues to rotateanother 180 degrees, the cam slot travels along the pin from position Bback to its original retracted position A at a relatively constant ratebecause the slope of the cam slot between these two points is relativelylinear. FIG. 15 illustrates the cam slot 1504 in an open and continuousconfiguration. Accordingly, as the inner cam member continues to rotatebeyond 360 degrees, the path of inner cam member is repeated and itcontinues to travel from position A to position B to position A. And dueto the substantially linear configuration of the cam slot profile fromposition A to position B, and vice versa, the inner cam member (andblade) extends and/or rotates at a substantially constant rate betweenpositions.

Referring again to FIGS. 7A, 7B, 7C and 7D, the inner cam member 700 mayalso comprise a step up 720 such that the diameter of the intermediateportion 728 is greater than the distal portion 732. As the inner cammember 700 rotates, and the cutting surface 712 extends beyond thedistal end of the outer cam member into its extended position, the stepup 720 of the inner cam member 700 contacts the abutment of the outercam member, thereby limiting the distance that the inner cam member 700may travel and/or may prevent the inner cam member from exiting orextending beyond the distal tip of the outer sheath (or outer cammember) in the event that the pin is sheared.

With reference to FIGS. 8A, 8B, 8C and 8D, an alternative exemplaryinner cam member 800 is depicted. The inner cam member 800 depicted inFIGS. 8A-8D is similar to the inner cam member 700 depicted in FIGS.7A-7D because the inner cam member 800 has a proximal portion 824, anintermediate portion 828, a distal portion 832 and a sharp cuttingsurface 712 with a flat profile at its distal end 808. Unlike the innercam member 700, which has a linear cam slot profile, however, the innercam member 800 has a cam slot 816, which when extended in atwo-dimensional plane, has a non-linear profile. For example, anillustration of a two-dimensional, non-linear cam slot profile 1700 isdepicted in FIG. 17.

Continuing to refer to FIG. 17, there is depicted cam slot 1704. As theflexible inner sheath extends distally within the outer sheath, thecooperation between the pin and the cam slot causes the inner cam memberto also rotate and travel toward and beyond the distal end of the outercam member. The rate and distance at which the inner cam member travelsis dependent upon the configuration of the cam slot, particularly theslope of the cam slot. If the profile of the cam slot, such as itsslope, is non-linear, then the rate and distance at which the inner cammember travels will vary as the inner cam member rotates and moves overthe pin along the cam slot path. For example, when the inner cam memberis in its fully retracted position (see FIG. 16A), the pin contacts thecam slot 1704 at position A identified as a first point marked + withinthe left hand side of FIG. 17. When the inner cam member is in itspartially extended position (see FIG. 16B), the pin contacts the camslot 1704 at a second point marked + and identified as position B withinFIG. 17. When the inner cam member is in its fully extended position(see FIG. 16C), the pin contacts the cam slot 1704 at another pointmarked + and identified as position C within FIG. 17. Thistwo-dimensional representation of the cam slot 1704 illustrates anon-linear profile of the cam slot because in order for the inner cammember to fully extend, it must travel at more than one rate fromposition A to position C. That is, the blade rotates at a firstpredetermined rate from position A to position B (partially extendedposition), and the blade rotates at a second predetermined rate fromposition A′ to position C (fully extended position).

For example, as the inner cam member rotates and the pin contacts thecam slot 1704, the cutting surface travels at a rate according to theprofile of the cam slot 1704 from its fully retracted position (see FIG.16A) to a position that is slightly beyond the distal end of the outercam member (see FIG. 16B) over about 90 degrees of rotation by the innercam member. The profile of the cam slot from position A to position B isgenerally linear, thereby causing the inner cam member to travel at agenerally constant rate between those two positions. As depicted in FIG.17, the blade extends a predetermined distance for the about of rotation(90 degrees) from position A to position B. Once the blade travels toits partially extended position B, the blade continues to rotate and theblade returns to its retracted position A′ over about 90 degrees ofrotation by the inner cam member. The profile of the cam slot fromposition B to position A′ is generally linear; therefore, the bladeextends at a generally constant rate between these two positions. As theas the inner cam member continues to rotate and the pin contacts the camslot 1704 beyond position A′ and toward position C over about another 90degrees of rotation, the blade extends a second predetermined distance.That is, the cutting surface travels beyond its partially extendedposition and to its fully extended position (see FIG. 16C). The profileof the cam slot from position A′ to position C is different than theprofile of the cam slot from position A to position B. Although theprofile of the cam slot from position A to position B is generallylinear, the first predetermined amount of extension (from position A toposition B) is less than the second predetermined amount of extension(from position A′ to position C). Thus, the profile of the cam slot fromposition A to position B is such that the blade extends a shorterdistance in comparison to extending from position A′ to position C for apredetermined amount of rotation (90 degrees), thereby providing moreprecise and finer control of the blade as it rotates and extends. Movingand extending the inner cam member at a generally constant rate for ashort distance provides the clinician precise control of the blade as itinitially extends beyond the outer sheath. Stated differently, theprofile of the cam slot from position A′ to position C is such that theblade extends further and more quickly for a predetermined amount ofrotation (90 degrees) after it is initially extended, thereby providingrelatively less precision and coarser control of the blade in comparisonto extending from position A to position B. Accordingly, the inner cammember and blade travel at a faster rate from position to A′ to positionC (and from position C to position A″) in comparison to traveling fromposition A to position B. In order for the blade to fully extend toposition C, the blade travels at more than one rate—one rate fromposition A to position B (and from position B to position A′) andanother rate from position A′ to position C. Thus, even though the ratesof travel from the position A to position B (and from position B toposition A′) and from position A′ to position C may both be relativelyconstant for each individual portion of travel, the overall rate oftravel is variable.

The discussion above discusses that the inner cam member travels atcertain rates (e.g., constant, variable). However, the rates are alsodependent upon the speed at which the inner sheath extends, and in turn,upon the speed of the means for actuating. For example, if the means foractuation includes a handle and one or more gears connecting the handleto the elongated inner sheath, then the rate at which the inner cammember rotates and extends is dependent upon how quickly the clinicianoperating the surgical device compresses the handle. Accordingly, thediscussion and/or comparison of the rates at which the blade extendstravels assumes that the means for actuating extends the inner sheath ata relatively constant speed. Regardless of whether this assumption iscorrect, the greater the amount of blade extension per predeterminedamount of rotation, the blade will extend at a greater rate and speed,thereby providing the surgical device with the ability to cut moretissue per rotation.

Although the discussion above with respect to FIGS. 8 and 17 onlydiscuss a certain number of linear and non-linear profile portions ofthe cam slot, that discussion is not intended to limit the scope of thisdisclosure to only a fixed number of linear and non-linear profileportions. Depending upon the desired rate(s) at which the blade mayrotate and extend, the cam slot may have additional multiple linear andnon-linear profile portions of the cam slot. Those of skill in the artwill understand how to make and use the disclosed aspects, embodiments,and/or configurations after understanding the present disclosure toadjust the distance, rate and rotational aspects at which the inner cammember (or other cam members) travels. All such configurations withinthe knowledge of one skilled in the art are considered within the scopeof this disclosure.

As mentioned above, the cam slot profile of FIG. 15 is an open andcontinuous configuration, thereby allowing the inner cam member tocontinuously rotate. The cam slot profile of FIG. 17, however, is aclosed configuration such that when the inner cam member reaches itsfully extended position (i.e., position C) or returns to position A″,the actuation means must be releases or reversed so that the inner cammay return to initial retracted position A. Although certain figures inthis disclosure only illustrated either the open or closed cam slotconfiguration, either configuration may be used with any of the innercam embodiments disclosed and/or discussed herein and are consideredwithin the scope of this disclosure.

With reference to FIGS. 9A, 9B, 9C and 9D, an alternative exemplaryinner cam member 900 is depicted. The inner cam member 900 depicted inFIGS. 9A-9D is similar to the inner cam member 900 depicted in FIGS.8A-8D because the inner cam member 900 has a proximal portion 924, anintermediate portion 928, a distal portion 932, and a cam slot 916 thatis similar to cam slot 816. Unlike the inner cam member 800, which has asmooth cutting surface, inner cam member 900 has a serrated cuttingsurface 912. The cutting surface 912 depicts fourteen (14) serrations.However, it may be preferable to have between twelve (12) and sixteen(16) serrations.

Although the cutting surface 912 illustrates a certain number ofserrations, FIGS. 9A-9D are not intended to represent the only numberand type of serrations that may be included in a serrated cuttingsurface. Depending upon the size of the surgical device, including thesheaths, and cam members, those of skill in the art will understand howto make and use the disclosed aspects, embodiments, and/orconfigurations after understanding the present disclosure to adjust thenumber, size and configurations of the serrations. All suchconfigurations within the knowledge of one skilled in the art areconsidered within the scope of this disclosure. For example, referringto FIGS. 11A, 11B, 11C and 11D, an alternative exemplary inner cammember 1100 is depicted having a cutting surface 1112 comprisingmultiple serrations in the form of a crown. Also, referring to FIGS.12A, 12B, 12C and 12D, an alternative exemplary inner cam member 1200 isdepicted having a cutting surface 1212 comprising multiple serrations inthe form of a hook crown. The cutting surface also need not be serrated,but merely include a plurality of notches formed therein. For example,with reference to FIGS. 13A, 13B, 13C and 13D, a further alternativeexemplary inner cam member 1300 is depicted having a cutting surfacewith four notches 1350 included therein. Furthermore, the notches maycomprise a myriad of different shapes and configurations, including butnot limited to any variation of a square, rectangle, rhombus,parallelogram, trapezoid, triangle, circle, ellipse, kite, etc.

The cutting surfaces discussed hereinbefore with respect to FIGS. 7, 8,9, 11, 12 and 13 are substantially parallel to the proximal edge of theinner cam members. In other words, the plane of the proximal end of theinner cam member and the plane of the distal end (e.g., cutting surface)of the inner cam member in these figures are substantially parallel. Theproximal and distal ends of the inner cam member, however, need not beparallel or co-planer. Rather, any of the cutting surfaced depicted inFIGS. 7, 8, 9, 11, 12 and 13 may be offset from the plane of theproximal end of the inner cam member. With reference to FIGS. 10A, 10B,10C and 10D, an alternative exemplary inner cam member 1000 is depicted.The plane of the cutting surface 1008 of the inner cam member 1000 isoffset from a plane parallel to the plane of the proximal end 1004 ofthe inner cam member at an angle α. It may be preferable for angle α tobe at an angle between zero degrees and ninety degrees.

The cam slots included within the inner cam members depicted FIGS. 7-13surround the circumference of the inner cam member one time. It mayadvantageous, however, for the cam slot to surround the inner cammember's circumference more than once. For example, with reference toFIG. 18, there is depicted an inner cam member 1800 having a cam slot1816 that travels more than 360 degrees around its circumference. Theportion 1848 of the cam slot 1816 that is closest to the distal end 1808of the inner cam member 1800 and that extends beyond the other end ofthe cam slot 1816 is substantially parallel to the planes of theproximal end 1804 and distal end 1808. The profile of cam slot 1816depicted in one dimension is illustrated in FIG. 20 as the inner cammember 1800 moves from a retracted position (see FIG. 19A) to apartially extended position (see FIG. 19B) and eventually to a fullyextended position (see FIG. 19C).

The configuration and profile of portion 1848 of the cam slot 1816prevents the inner cam member 1800 from moving from its refractedposition, even if the inner cam member 1800 begins to rotate. That is,the inner cam member 1800 remains stowed in its retracted position aslong as the pin engages only portion 1848 of cam slot 1816, therebyinsuring that the blade is completely retracted as the clinicianmaneuvers the surgical device within the patient's vascular system.Referring to FIG. 20, there is depicted a two-dimensional cam slotprofile of the configuration of the cam slot 1816 of FIG. 18. The camslot profile depicted in FIG. 20 is similar to the configuration of thecam slot profile depicted in FIG. 17, with the exception that the camslot profile depicted in FIG. 20 further includes a portion thatsurrounds the circumference of the inner cam member more than once. Thatis, the cam slot is included in about another 90 degrees of travelaround the circumference of the inner cam member over and above the 360degrees of travel. This additional portion—the portion that extendsaround the circumference of the inner cam member more than 360degrees—is depicted as the substantially flat profile portion to thebottom right hand side of FIG. 20 that begins with a point marked + andidentified as position A. This substantially flat profile portioninsures that the blade remains stowed within the outer cam member as theinner cam member begins to rotate, thereby increasing the safety of thedevice and minimizing the likelihood of the blade being exposed beyondthe distal end of the outer cam prior to actuation. Although FIG. 20illustrates the flat portion of the cam slot as an extended in anembodiment with a cam slot greater than 360 degrees around thecircumference of the inner cam member, the flat portion, which createsthe stowed position, can be included within a cam slot that is equal toor less than 360 degrees around the circumference of the inner cammember.

With reference to FIG. 21, there is depicted an inner cam member 2100having a cam slot 2116 that travels about 720 degrees around itscircumference. The profile of cam slot 2116 depicted in two dimensionsis illustrated in FIG. 23 as the inner cam member 2100 moves from aretracted position (see FIG. 22A) to a partially extended position (seeFIG. 22B) and eventually to a fully extended position (see FIG. 22C).Referring to FIG. 23, the blade extends from position A, whichcorresponds to the retracted position of FIG. 22A, to position B, whichcorresponds to the partially extended position of FIG. 22B over about180 degrees of rotation by the inner cam member 2100. The blade thenretracts from position B to position A′ over about 180 degrees ofrotation by the inner cam member 2100. The blade can then extends fromposition A′, which corresponds to the retracted position of FIG. 22A, toposition C, which corresponds to the fully extended position of FIG. 22Cover about 180 degrees of rotation by the inner cam member 2100. Lastly,the blade retracts from position C to position A″ over about 180 degreesof rotation by the inner cam member 2100. The benefit of increasing thelength of the cam slot 2116 to a length greater than the circumferenceof the inner cam member to twice as long as the circumference of theinner cam member (i.e., 720 degrees) in comparison to the cam slot ofFIG. 17, which is only passes over the circumference one time (i.e., 360degrees), is that the blade and inner cam member can rotate about twiceas much for the same amount of extension. Accordingly, the blade has theability to rotate and potentially create a greater amount of cuttingaction against the tissue for a predetermined amount of extension.

The discussion above with respect to FIG. 23 explains how the bladetravels according to the cam slot profile for a full 720 degrees ofrotation because the inner cam member includes a double lobe camprofile. During actuation, however, the inner cam member does not needto travel the entire 720 degrees of rotation. For example, the clinicianoperating the surgical device can actuate the means for actuation suchthat the inner cam member repeats the travel from position A to positionB rather than continuing onward to position C. Allowing the clinician torepeat the inner cam member's path of travel from position A to positionB allows the clinician to operate the surgical device in a precisioncutting mode for a longer period of time. Alternatively, the clinicianoperating the surgical device can actuate the means for actuation suchthat the inner cam member repeats the travel from position A′ toposition C rather than restarting from position A and moving to positionC. Allowing the clinician to repeat the inner cam member's path oftravel from position A′ to position C allows the clinician to operatethe surgical device in a coarser cutting mode for a longer period oftime. This allows the clinician to alternate the use of the surgicaldevice (1) in either a precision cutting mode or a coarse cutting mode,(2) by alternating between the precision cutting mode and the coarsecutting mode, and/or (3) using a variable mode, which includes thecombination of both the precision cutting mode and coarse cutting mode.

As previously discussed with respect to FIG. 4, the distal end of theflexible outer sheath 404 may be smooth and evenly rounded at its mostdistal point. Alternatively, the distal end of the outer sheath may notbe smooth. Rather, the distal end of the outer sheath may be uneven inorder to increase the outer sheath's ability to engage tissue. Byengaging tissue, the outer sheath may increase its ability to remainstationary within the subject's vascular system as the inner cam memberand blade rotate and extend into such tissue, thereby potentiallyminimizing undesirable rotation and/or movement of the outer sheath orsurgical device.

FIGS. 29A, 29B, 29C and 29D depict a distal tip 2900 of the outer sheathaccording to an embodiment of the disclosure. The distal tip 2900illustrated in these figures is depicted as a separate component. Thoseof skill in the art will understand how to make and use the disclosedaspects, embodiments, and/or configurations of the distal tip afterunderstanding the present disclosure to adjust the location, size,configuration and/or type of indicator. For example, the distal tip,particularly its uneven configuration, may be created in the distalportion of the outer sheath, the outer cam member and/or a combinationof the outer sheath and outer cam member. All such configurations withinthe knowledge of one skilled in the art are considered within the scopeof this disclosure. For the purposes of this disclosure, the “distaltip,” particularly the distal tip of the outer sheath, shall mean andinclude a separate component attached to the outer sheath, the distalportion of the outer sheath, the outer cam member located at the distalend of the sheath, a combination of any of the preceding, and/or anyother distal portion or component of the surgical device intended tocontact tissue.

Continuing to refer to FIGS. 29A-29D, distal tip 2900 has a proximal end2908 and a distal end 2912. The proximal end 2908 of the distal tip 2900extends from or is attached to the outer sheath, the outer cam member,etc., and/or a combination thereof. The distal tip 2900 also includes aplurality of notches 2904 extending proximally from its distal end 2912.The notches 2904 create an uneven profile at the distal end 2912 of thedistal tip, and this uneven profile facilitates the distal tip'sengagement with the tissue or other material within the subject'svasculature, thereby holding the outer sheath stationary while the bladerotates and extends into the tissue.

FIGS. 29A-29D depicts six notches 2904 that have a generally rectangularshape that taper upwardly from the distal end 2904 toward the proximalend 2908 until the notches intersect and become flush with the exteriorsurface of the distal tip 2900. The notches 2904 are formed by removingmaterial from the distal end 2904 of the distal tip. Notches may also beformed by adding material at predetermined intervals along the perimeterof the distal tip, such that the notches are created and located betweenthe additional materials. Depending upon the size and configuration ofthe surgical device, particularly its distal tip, those of skill in theart will understand how to make and use the disclosed aspects,embodiments, and/or configurations after understanding the presentdisclosure to adjust the number, location, size, configuration and/ortype of notches. All such notch configurations within the knowledge ofone skilled in the art are considered within the scope of thisdisclosure.

With reference to FIGS. 30A-30D there is depicted an alternativeexemplary distal tip 3000 has a proximal end 3008 and a distal end 3012.The notches 3104 included within this distal tip 3000 have a generallynarrower rectangular shape in comparison to the notches 2904 of distaltip 2900 depicted in FIGS. 29A-29D. Due to the narrower configuration ofthe notches 3014 illustrated in FIGS. 30A-30D, the distal tip 3000includes three times as many notches, for a total of eighteen, incomparison to the number of notches 2904 in distal tip 2900. AlthoughFIGS. 29A-D and FIGS. 30A-D depict rectangular shaped notches 2904,3004, the distal tip may include notches of any desirable shape thatwill engage tissue, including but not limited to any variation of asquare, rhombus, parallelogram, trapezoid, triangle, circle, ellipse,kite, etc. For example, FIGS. 31A-31D depict a further alternativeexemplary distal tip 3100 having V-shaped notches 3104 extending fromdistal end 3112 toward proximal end 3108.

The notches 2904, 3004, and 3104 included in distal tips 2900, 3000, and3100, respectively, are configured to engage tissue and to prevent theouter sheath from rotating as the blade rotates and extends into suchtissue. Inclusion of the notches in the outer sheath may also enhancethe surgical devices ability to cut tissue because the combination ofnotches within the distal tip and notches within the cutting surface ofthe inner cam member may create a shearing force, thereby increasing theoverall amount of cutting force applied to the tissue. Accordingly, thenotches of the distal tip may also be configured to include a sharpblade profile, such as the serrated and notched blades depicted in FIGS.9, 11, 12 and 13 and any equivalents thereof.

With reference to FIGS. 32A and 32B, there is depicted a distal tip 3202and an inner cam member 3208. The inner cam member 3208 has a pluralityof notches 3212 creating a serrated-type blade, and distal tip 3202 hasa plurality of notches 3204 that have a substantially similar size andshape as the notches 3212 within the inner cam member 3208. FIG. 32Adepicts the inner cam member 3208 in a retracted position because thecutting surface does not extend beyond the distal end of the distal tip.When the inner cam member 3208 is in its distal position, it may bepreferable that the notches 3204, 3212 of the inner cam member 3208 andthe distal tip 3202 substantially align in order to improve the surgicaldevice's ability, particularly the distal tip's ability, to engagetissue. Referring to FIG. 32B, as the inner cam member 3208 begins torotate and extend outwardly from its retracted position, the serrations3216 begin to pass over the notches 3204 in the distal tip 3202, therebycreating a shearing force against the tissue and potentially increasingthe device's cutting ability.

With reference to FIG. 24, there is a depicted an alternative embodimentof surgical device 2400 that comprises an indicator 2440 indicative ofhow far the blade of the inner cam member has traveled and/or hastraveled beyond the distal end of the outer sheath. The indicator 2440in FIG. 24 is located on the top of the distal portion of the handle2404. Specifically, the indicator 2440 is located between the distal endof the handle 2404 and a vertically extending portion 2438 of the handlethat encases components, such as gears, within the handle 2404.Indicator 2440 may include indicia, such as numbers or dimensionsindicative of the length that the blade has traveled and/or has traveledbeyond the distal end of the outer sheath. In addition and/or in lieu ofthe indicia, the indicator 2440 may include color coded regions (e.g.,green, yellow, orange, red, etc.), such that differently colored regionsconvey to the clinician whether it is more or less safe to move theentire surgical device, including the sheaths, within the patient'svasculature depending upon whether the cutting blade is exposed and/orhow much of it is exposed. The indicator 2440 may also be directlyand/or indirectly connected to the actuating means of the surgicaldevice.

Although the indicator 2440 in FIG. 24 is located on the top of thedistal portion of the handle 2404, FIG. 24 is not intended to representthe only location and type of indicator that may be included in aserrated cutting surface. Depending upon the size and configuration ofthe surgical device, particularly its handle and actuating mechanism(s),those of skill in the art will understand how to make and use thedisclosed aspects, embodiments, and/or configurations afterunderstanding the present disclosure to adjust the location, size,configuration and/or type of indicator. All such configurations withinthe knowledge of one skilled in the art are considered within the scopeof this disclosure. For example, referring to FIG. 25, an alternativeexemplary surgical device 2500 comprising an indicator 2540 depicted onthe proximal, top portion of handle 2504. Also, referring to FIG. 26, analternative exemplary surgical device 2600 comprising an indicator 2640depicted on the side of the handle 2640, particularly, the indicator2640 is located on a vertically extending portion 2638 of the handle2604 that encases components, such as gears. The indicator also does notneed to be a mechanically actuated indicator. For example, if a motor isused to actuate the sheath, the indicator can be a color-coded light, orother type of electrically based indicators, located on the top of thehandle as depicted with reference to FIG. 27. Additionally, the color(e.g., green, yellow, orange, red, etc.) of the light, the brightness ofthe light and/or whether light remains constant or blinks (including thefrequency of blinking) may change as the blade travels from itsretracted position to its extended position.

Additionally, the indicator need not be located on the surgical deviceor any portion thereof, such as the handle. Rather, the indicator can belocated external to the surgical device. That is, the surgical devicemay include a communication port that transmits the indictor signal(s)to a remote display and/or a remote device. For example, the surgicaldevice may be connected to a remote fluoroscopy monitor, either via acable or wirelessly, thereby allowing the monitor to display theposition of the cutting surface (i.e., blade), inner cam, inner sheathand/or any other component of the surgical device. Transmitting thedevice's positional information to the monitor potentially allows theclinician to view the position of the blade on the same monitor that theclinician is using to perform the surgical procedure while navigatingthe patient's vasculature.

In the appended figures, similar components and/or features may have thesame reference label. Further, various components of the same type maybe distinguished by following the reference label by a letter thatdistinguishes among the similar components. If only the first referencelabel is used in the specification, the description is applicable to anyone of the similar components having the same first reference labelirrespective of the second reference label.

Presented herein are embodiments of a tissue separating device, system,and method. As described herein, the device(s) may be electrical,mechanical, electro-mechanical, and/or combinations thereof.

A number of variations and modifications of the disclosure may be used.It would be possible to provide for some features of the disclosurewithout providing others.

In some embodiments, the systems and methods of this disclosure may beimplemented in conjunction with a special purpose computer, a programmedmicroprocessor or microcontroller and peripheral integrated circuitelement(s), an ASIC or other integrated circuit, a digital signalprocessor, a hard-wired electronic or logic circuit such as discreteelement circuit, a programmable logic device or gate array such as PLD,PLA, FPGA, PAL, special purpose computer, any comparable means, or thelike. In general, any device(s) or means capable of implementing themethodology illustrated herein may be used to implement the variousaspects of this disclosure. Exemplary hardware that may be used for thedisclosed embodiments, configurations and aspects includes computers,handheld devices, telephones (e.g., cellular, Internet enabled, digital,analog, hybrids, and others), and other hardware known in the art. Someof these devices include processors (e.g., a single or multiplemicroprocessors), memory, nonvolatile storage, input devices, and outputdevices. Furthermore, alternative software implementations including,but not limited to, distributed processing or component/objectdistributed processing, parallel processing, or virtual machineprocessing may also be constructed to implement the methods describedherein.

The present disclosure, in various aspects, embodiments, and/orconfigurations, includes components, methods, processes, systems and/orapparatus substantially as depicted and described herein, includingvarious aspects, embodiments, configurations embodiments, subcombinations, and/or subsets thereof. Those of skill in the art willunderstand how to make and use the disclosed aspects, embodiments,and/or configurations after understanding the present disclosure. Thepresent disclosure, in various aspects, embodiments, and/orconfigurations, includes providing devices and processes in the absenceof items not depicted and/or described herein or in various aspects,embodiments, and/or configurations hereof, including in the absence ofsuch items as may have been used in previous devices or processes, e.g.,for improving performance, achieving ease and/or reducing cost ofimplementation.

For example, the disclosure discusses two sheaths—and inner sheath andan outer sheath. Additionally, the disclosure discusses using two cammembers—an outer stationary cam member and an inner telescopically,rotatable cam member. With reference to FIG. 28, it may be beneficial touse additional rotatable sheaths, stationary sheaths, stationary cammembers and/or rotatable cam members. FIG. 28 depicts an alternateexemplary embodiment of the distal portion of the sheaths. This figureillustrates a flexible stationary outer sheath 2816, a flexibleextendable intermediate sheath 2804, and a flexible extendable innersheath 2826. Coupled to the outer sheath 2816 is a rotatable outer cammember 2826. Coupled to the intermediate sheath 2804 is a rotatableintermediate cam member 2808. Coupled to the inner sheath 2826 is arotatable inner cam member 2812. The inner cam member 2812 is connectedto the intermediate cam member 2808 by pin 2810. The intermediate cammember 2808 is connected to the outer cam member by pin 2824. As theinner sheath 2826 extends distally, the inner cam member rotates andtravels according to the profile of cam slot 2830 in which the pin 2810sits. Similarly, as the intermediate sheath 2804 extends distally, theintermediate cam member rotates and travels according to the profile ofcam slot 2834 in which the pin 2824 sits. Utilizing multiple rotatableand extendable sheaths, as well as rotatable cam members, allows thedevice to increase the extension and rotation of the cutting surface.This is only one example of an alternative embodiment, and dependingupon the amount of blade extension and/or desired rotation and/ormovement of the cutting blade, those of skill in the art will understandhow to make and use the disclosed aspects, embodiments, and/orconfigurations after understanding the present disclosure to adjust thelocation, size, configuration and/or type of indicator. All suchconfigurations within the knowledge of one skilled in the art areconsidered within the scope of this disclosure.

Additionally, various types of cams, such as single lobe cams and doublelobe cams are discussed within this disclosure. Other lobe camconfigurations, such as triple lob cams, may be used. Similarly, theincrement of the additional length of cam slot need not be 90 degreesbeyond 360 degrees. For example, the additional length of cam slot canbe in increments of 5, 10, 15, 30, 45, 60 degrees, etc. Furthermore,although the slope of the cam slot between two positions and/or pointshas been described as generally linear, the slope between two pointsneed not be linear. Rather, the cam slot and/or slope of the cam slotcan be non-linear, such as a sinusoidal shape, which may or may not havea generally linear portion. The sinusoidal shape, particularly at thetransition points allows for a smooth transition of the inner cammember, inner sheath, and/or cutting surface from an extended directionto retracted direction through such positions while maintaining arelatively constant rate of rotation, thereby allowing the cuttingsurface to continue to rotate and cut the tissue through suchtransition.

Moreover, although a pin and slot cam configuration is discussed withinthis disclosure, other possible cam configurations may be used. Forexample, a captured ring cam configuration may be used. A captured ringcam configuration may include a ring that is attached to one of theinner sheath (or inner member attached to the inner sheath) or the outersheath (or outer member attached to the outer sheath) that is capturedby two angled lobes on the other sheath (or member). Although the ringmay be captured by one lobe, it may be preferred for the ring to becaptured by two lobes—one on each side of the ring—such that cuttingsurface may be forced in both a proximal direction (toward a refractionposition) and distal direction (toward an extended direction). Thebenefit of being able to force the cutting surface in both directionswith the aid of the captured cam configuration potentially negates theneed for a spring or other retraction mechanism to force the innersheath (or inner member) and cutting surface back within the outersheath (or outer member.

The foregoing discussion has been presented for purposes of illustrationand description. The foregoing is not intended to limit the disclosureto the form or forms disclosed herein. In the foregoing Summary forexample, various features of the disclosure are grouped together in oneor more aspects, embodiments, and/or configurations for the purpose ofstreamlining the disclosure. The features of the aspects, embodiments,and/or configurations of the disclosure may be combined in alternateaspects, embodiments, and/or configurations other than those discussedabove. This method of disclosure is not to be interpreted as reflectingan intention that the claims require more features than are expresslyrecited in each claim. Rather, as the following claims reflect,inventive aspects lie in less than all features of a single foregoingdisclosed aspect, embodiment, and/or configuration. Thus, the followingclaims are hereby incorporated into this Summary, with each claimstanding on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the description has included description of one or moreaspects, embodiments, and/or configurations and certain variations andmodifications, other variations, combinations, and modifications arewithin the scope of the disclosure, e.g., as may be within the skill andknowledge of those in the art, after understanding the presentdisclosure. It is intended to obtain rights which include alternativeaspects, embodiments, and/or configurations to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A device for removing an implanted object from abody vessel, the device comprising: a handle; an elongated sheath havinga proximal end, a distal end, and a lumen extending from the distal endtoward the proximal end, wherein the lumen is configured to receive animplanted object, the elongated sheath further comprising a proximalportion and a distal portion; a hollow circular outer member attached tothe distal portion of the elongated sheath; a pin attached to the hollowcircular outer member and extending inwardly thereof; and a hollowcircular inner member located within the outer member, the hollowcircular inner member comprising a proximal end, a distal end and anexterior surface therebetween, the distal end comprising a cuttingsurface, the exterior surface of the inner member comprising a cam slotfor receipt of and cooperation with the pin such that upon actuation ofthe handle, the inner member rotates and the distal end of the innermember extends beyond the distal end of the elongated sheath.
 2. Thedevice of claim 1, wherein the cam slot has a length that is about thesame as the circumference of the hollow circular inner member.
 3. Thedevice of claim 1, wherein the cam slot has a length that is shorterthan the circumference of the hollow circular inner member.
 4. Thedevice of claim 1, wherein the cam slot has a length that is longer thanthe circumference of the hollow circular inner member.
 5. The device ofclaim 4, wherein the length of the cam that is longer than thecircumference of the hollow circular inner member is substantiallyparallel to the proximal end of the hollow circular inner member.
 6. Thedevice of claim 1, wherein the cam slot has a length that is about twicethe circumference of the hollow circular inner member.
 7. The device ofclaim 1, wherein the cam slot surrounds the entire circumference of thehollow circular inner member.
 8. The device of claim 7, wherein the camslot surrounds the circumference of the hollow circular inner membermore than once.
 9. The device of claim 7, wherein a portion of the camslot that surrounds the circumference of the hollow circular innermember more than once is substantially parallel to the proximal end ofthe hollow circular inner member.
 10. The device of claim 7, wherein thecam slot surrounds the circumference of the hollow circular inner membertwice.
 11. The device of claim 1, wherein the configuration of the camslot is configured to move the distal end of the hollow circular innermember to extend beyond the distal end of the elongated sheath apredetermined length.
 12. The device of claim 11, wherein the hollowcircular inner member rotates about one revolution in order to drive thedistal end of the hollow circular inner member to extend saidpredetermined length beyond the distal end of the elongated sheath. 13.The device of claim 11, wherein the hollow circular inner member rotatesabout two revolutions in order to drive the distal end of the hollowcircular inner member to extend said predetermined length beyond thedistal end of the elongated sheath.
 14. The device of claim 11, whereinthe hollow circular inner member rotates between one revolution and tworevolutions in order to drive the distal end of the hollow circularinner member to extend said predetermined length beyond the distal endof the elongated sheath.
 15. The device of claim 11, wherein the hollowcircular inner member rotates more than two revolutions in order todrive the distal end of the hollow circular inner member to extend saidpredetermined length beyond the distal end of the elongated sheath. 16.The device of claim 1, wherein the cam slot has a first portion and asecond portion, wherein the first portion is configured to extend thehollow circular inner member a first predetermined length beyond thedistal end of the elongated sheath, and wherein the second portion isconfigured to extend the hollow circular inner member a secondpredetermined length beyond the distal end of the elongated sheath. 17.The device of claim 16, wherein the first predetermined length isdifferent than the second predetermined length.
 18. The device of claim17, wherein the first predetermined length is shorter than the secondpredetermined length.
 19. The device of claim 17, wherein the firstpredetermined length is longer than the second predetermined length. 20.The device of claim 1, wherein the cam slot has a first portion and asecond portion, wherein the first portion is configured to extend thehollow circular inner member at a first predetermined rate, and whereinthe second portion is configured to extend the inner member a secondpredetermined rate.
 21. The device of claim 20, wherein the firstpredetermined rate is different than the second predetermined rate. 22.The device of claim 21, wherein the first predetermined rate is lessthan the second predetermined rate.
 23. The device of claim 21, whereinthe first predetermined rate is greater than the second predeterminedrate.
 24. The device of claim 1, further comprising an indicatorindicative of the amount of extension that the inner member extendsbeyond the distal end of the elongated sheath.
 25. The device of claim1, wherein the indicator is located on the handle.
 26. A method ofcutting tissue surrounding at least a portion of an implanted objectusing the device of claim
 1. 27. A method of cutting tissue surroundingat least a portion an object implanted within a body vessel, the methodcomprising the steps of: placing an the implanted object into a lumen ofan elongated sheath, the elongated sheath comprising a distal tip and atubular member housed within at least a portion of the distal tip,wherein the tubular member has a cutting surface facing distally;rotating and extending the cutting surface of the tubular member beyondthe distal tip and into the tissue at a first rate for a first distance;and rotating and extending the cutting surface of the tubular memberbeyond the distal tip and into the tissue at a second rate for a seconddistance.
 28. The method of claim 27, further comprising repeating atleast one of the rotating and extending steps.
 29. The method of claim27, wherein at least one of the rotating and extending steps comprisescompressing a handle from which the elongated sheath extends.
 30. Themethod of claim 18, wherein at least one of the rotating and extendingsteps is electrically initiated.